Evaluation of a Tdap-IPV (Tetanus, Diphteria, Pertussis and Inactivated Polio) Vaccination Remedial Strategy on Vaccination Coverage in Patients 65 Years of Age or Older (HOSPIVAC)

Evaluation of a Tdap-IPV Vaccination Remedial Strategy on Vaccination Coverage in Patients 65 Years of Age or Older in the French County of Sarthe

In France, vaccination coverage is insufficient (in 2002, 71.2% coverage for tetanus, 41.9% for poliomyelitis and 33.7% for diphteria). These numbers decrease significantly with age: coverage for people aged over 65 was 60.5%, 13.3% and 10.5% for tetanus, poliomyelitis and diphteria coverage respectively.

The primary objective of this study is to evaluate the impact of a hospital based vaccination remedial strategy for Tdap-IPV (tetanus, diphteria, pertussis and polio vaccine) in patients 65 years of age or older.

Secondary objectives are to measure the vaccination coverage of patients aged 65 years or older hospitalised in a medical ward in our hospital, to evaluate their knowledge of their vaccination coverage, and to evaluate the socio-demographic factors associated with vaccination coverage.

Study Overview

• Status: Unknown
• Conditions: Vaccination
• Intervention / Treatment: Biological: Remedial vaccination

• Study Type: Interventional
• Enrollment (Anticipated): 402
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christelle Jadeau, P.D.; Phone Number: 0243434343; Email: cjadeau@ch-lemans.fr
• Study Contact Backup: Name: Jean-Christophe Callahan, M.D.; Phone Number: 0243434343; Email: jccallahan@ch-lemans.fr

Study Locations

• France
  • Le Mans, France, 72 000
    • Recruiting
    • Centre Hospitalier Le Mans
    • Contact: Christelle Jadeau, PD; Phone Number: 37 482 0 (33) 2 43 43 43 43; Email: cjadeau@ch-lemans.fr
    • Contact: Jean-Christophe Callahan, MD; Phone Number: 37 520 0 (33) 2 43 43 43 43; Email: jccallahan@ch-lemans.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 65 years or older
• Patients capable of understanding and giving informed consent to participate in the study
• Valid social security coverage

Exclusion Criteria:

• Patients under judicial safeguard measures
• Refusal to participate in the study
• Vaccination contra-indication
• Patient already included in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intervention arm; if the patients vaccinations are up to date: no remedial vaccination is done and the patient is informed of the next remedial vaccination date; if the patients vaccinations are not up to date: remedial vaccination is realised in the unit in the absence of contraindication, in case of a temporary contraindication the vaccination will be performed on an outpatient basis by the patients primary care provider and he will be given a prescription at hospital discharge for the remedial vaccination.	Biological: Remedial vaccination; if the patients vaccinations are up to date: no remedial vaccination is done and the patient is informed of the next remedial vaccination date; if the patients vaccinations are not up to date: remedial vaccination is realised in the unit in the absence of contraindication, in case of a temporary contraindication the vaccination will be performed on an outpatient basis by the patients primary care provider and he will be given a prescription at hospital discharge for the remedial vaccination.
NO_INTERVENTION: Standard care; if the patients vaccinations are up to date: no remedial vaccination is done and the patient is informed of the next remedial vaccination date; if the patients vaccinations are not up to date: the patient will be informed that a remedial vaccination is necessary and that he should contact his primary care provider after hospital discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in immunization rate after a hospital centered remedial strategy for Tdap-IPV vaccination in patients 65 years or older	Difference in the increase in vaccination coverage between the two arms, measured as a percentage	two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunisation rate among patients 65 years of age or older in the Sarthe department of France	Pre-intervention vaccination coverage rate in both arms, measured as a percentage	two months
Immunisation rate according to sex among patients 65 years or older	Sex of patients included in the study	two months
Immunisation rate according to primary care coverage among patients 65 years of age or older	Primary care coverage is defined as having a regular primary care physician registered as such with French social security.	two months
Immunisation rate according to socio professional category	Socio professional category defined according to the French national institute for statistics and economic studies (INSEE)	two months

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans
• Investigators: Principal Investigator: Sophie Blanchi, M.D., Centre Hospitalier Du Mans

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 24, 2018
• Primary Completion (ANTICIPATED): November 1, 2019
• Study Completion (ANTICIPATED): January 1, 2020

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (ACTUAL): July 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: vaccination coverage
• Other Study ID Numbers: CHM-2017-S6/06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No